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A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension

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ClinicalTrials.gov Identifier: NCT00667719
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : June 7, 2021
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Aliskiren Drug: Amlodipine Drug: Hydrochlorothiazide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 564 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 28 to 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren / Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension
Actual Study Start Date : June 5, 2008
Actual Primary Completion Date : October 5, 2009
Actual Study Completion Date : October 5, 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aliskiren/Amlodipine/Hydrochlorothiazide
Participants received aliskiren 300 milligrams (mg) plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning.
Drug: Aliskiren
300 mg tablet

Drug: Amlodipine
5 mg tablet

Drug: Hydrochlorothiazide
12.5 mg and 25 mg capsule




Primary Outcome Measures :
  1. Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death [ Time Frame: 54 weeks ]
    An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, even if the event is not considered to be related to study drug. An SAE was defined as an event which was fatal or life-threatening, resulted in persistent or significant disability/incapacity, constituted a congenital anomaly/birth defect, required inpatient hospitalization or prolongation of existing hospitalization, was medically significant, i.e. defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.


Secondary Outcome Measures :
  1. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline, Weeks 28 and 54 endpoint ]
    The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the participant in a sitting position for five minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28.

  2. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: Baseline, Weeks 28 and 54 endpoints ]
    The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the participant in a sitting position for five minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28.

  3. Percentage of Participants Achieving the Blood Pressure Control Target of <140/90 mmHg [ Time Frame: Weeks 28 and 54 endpoints ]
    Blood pressure control was defined as having a mean sitting diastolic blood pressure <90 mmHg and a mean sitting systolic blood pressure <140 mmHg. Percentage of participants achieving the blood pressure control of < 140/90 mmHg were reported. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28 and Week 54 Endpoint was the last non-missing measurement value after Week 28.

  4. Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Diastolic Blood Pressure [ Time Frame: Weeks 28 and 54 endpoints ]
    Diastolic Blood pressure response was defined as a mean sitting diastolic blood pressure <90 mmHg or a >=10 mmHg reduction from baseline value. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28.

  5. Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Systolic Blood Pressure [ Time Frame: Weeks 28 and 54 endpoints ]
    Systolic blood pressure response was defined as a mean sitting systolic blood pressure <140 mmHg or a >=20 mmHg reduction from baseline value. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients 18 years of age or older
  • Male or female participants are eligible.
  • Mean sitting diastolic blood pressure (msDBP) and mean sitting systolic blood pressure (msSBP) Requirements:

    • For newly diagnosed/untreated participants, msDBP ≥ 100 and < 120 millimeters of mercury (mmHg), and/or msSBP ≥ 160 and < 200 mmHg at Visit 1 and Visit 2.
    • For previously treated participants, msDBP ≥ 100 and < 120 mmHg, and/or msSBP ≥ 160 and < 200 mmHg at Visit 2, Visit 3, or Visit 4.
  • For participants requiring tapering off their previous antihypertensive medication, they must meet the above criteria and completely discontinue all antihypertensive treatment prior to entering the treatment phase of the study.
  • Participants who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).

Exclusion Criteria:

  • Inability to discontinue all prior antihypertensive medications safely for a period of 1 week to 4 weeks as required by the protocol.
  • Participants on three antihypertensive drugs with msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg at Visit 1.
  • Participants on four or more antihypertensive drugs at Visit 1.
  • Participants with an msSBP ≥ 200 and msDBP ≥ 120 mmHg anytime during the washout period of the study Visit 1-4 must be discontinued from the study.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (>= 5 milli-international units per milliliter mIU/mL).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667719


Locations
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United States, Texas
Investigative Site
Houston, Texas, United States
Belgium
Investigative Site
Belgium, Belgium
Egypt
Investigative Site
Egypt, Egypt
Germany
Investigative Site
Germany, Germany
Poland
Investigative Site
Poland, Poland
Slovakia
Investigative Site
Slovakia, Slovakia
Spain
Investigative Site
Spain, Spain
Turkey
Investigative Site
Turkey, Turkey
Sponsors and Collaborators
Novartis
Investigators
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Study Chair: Novartis Novartis
Publications of Results:
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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00667719    
Other Study ID Numbers: CSAH100A2301
2008-001242-10 ( EudraCT Number )
First Posted: April 28, 2008    Key Record Dates
Results First Posted: June 7, 2021
Last Update Posted: June 7, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis:
Essential hypertension
High blood pressure
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Hydrochlorothiazide
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors